Original Article DISSOLUTION PROFILE OF AMBROXOL HCl TABLET WITH ADDITIONAL VARIATIONS OF LUDIPRESS ® AND LACTOSE USING THE DIRECT PRESS METHOD RESMI MUSTARICHIE * , DOLIH GOZALI, DRADJAD PRIAMBODO Faculty of Pharmacy, Universitas Padjadjaran, Hegarmanah, Jatinangor, Jawa Barat 45363, Indonesia Email: resmi.mustarichie@unpad.ac.id Received: 31 Jan 2020, Revised and Accepted: 06 Mar 2020 ABSTRACT Objective: The drug will provide a therapeutic effect when dissolved so that it is easily absorbed. The process of dissolving drugs is called dissolution. Additional substances contained in pharmaceutical preparations, one of which serves to accelerate the solubility of active substances. The aim of this study was to obtain a comparative composition of Ludipress® and lactose additives suitable for producing ambroxol HCl tablets that met the ambroxol acceleration ambroxol in the body. Methods: Ambroxol HCl tablets were made by direct pressing method. For research purposes, 4 formulas with variations of Ludipress® and Lactose were designed. The tablet was then evaluated, which includes uniformity in weight, diameter, thickness, hardness, friability, disintegration time, and dissolution. Data obtained in the analysis using the perfect random block design method (DBAS) with α = 0.05 where blocks and groups were used. Results: From the results of the Mass Printing Evaluation of Tablets, it was found that the four formulas that were designed met the resting angle, flow rate, real density, compressed density, and compressibility met existing requirements. The results of evaluation tablets, which included uniformity of weight, uniformity of size, hardness, friability, disintegration time, and dissolution test, were found that only F1 formula did not meet uniformity requirements. All four formulas meet the Indonesian pharmacopeia requirements for time of violence, fragility and disintegration. The dissolution test results showed that in the 45-minute test each percent dissolved concentration of the active substance for F1, F2, F3, and F4 was 58.77974, 66.91104, 80.09946, and 64.02293 suggesting only the F3 formula fulfilled the dissolution requirements according to European Pharmacopoeia which stated that the concentration of dissolved active tablets should not be less than 75% during the 45-minute test. Conclusion: The formula that met the solubility requirements consisted of an additional 69% Ludipress® and 10% lactose with a solubility value of 80.09%. Keywords: Dissolution profile, Ambroxol HCl tablets, Direct press, Ludipress®, Lactose © 2020 The Authors. Published by Innovare Academic Sciences Pvt Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/) DOI: http://dx.doi.org/10.22159/ijap.2020v12i3.37001. Journal homepage: https://innovareacademics.in/journals/index.php/ijap INTRODUCTION Dissolution test is one of the tests most often used to characterize drugs and control the quality of dosage forms. Investigation through dissolution carried out on powders enables optimization of formulation factors [1, 2]. Optimal dissolution can be obtained if the tablet can be crushed into particles quickly. It is generally known several years ago that before absorption occurs, a solid drug must undergo disintegration into small particles and release the active substance [3, 4]. Actually, there was some research regarding the ambroxol HCl tablet. Sharma et. al [5], for example, wrote simultaneous estimation of ambroxol hydrochloride and cetirizine hydrochloride in pharmaceutical tablets using simultaneous equation spectrophotometric. Basak et. al [6] mentioned formulation and release behavior of sustained-release ambroxol hydrochloride HPMC matrix tablet. A study on the effect of 20 mg ambroxol hydrochloride on acute cough was articled by Hull University Teaching Hospitals NHS Trust [7]. In vitro characterization and release study of ambroxol hydrochloride matrix tablets prepared by direct compression was reported by Abd-Elbary et. al [8, 9]. Rangnath et. al [10] studied Development and validation for UV Spectrometric estimation of ambroxol hydrochloride in bulk and tablet dosage form using the area under curve method. Kinetic studies of ambroxol were studied by Akhter et. al [11] and Hang et. al [12]. Method for simultaneous estimation of levofloxacin hemihydrate and ambroxol hydrochloride in bulk and its pharmaceutical dosage form was reported by Sumithra et. al [13]. Potawale et. al [14], however, used Liquid chromatography tandem-Mass spectromethry to develop a method for simultaneous analysis of paracetamol, guafenesin, phenylephrine hydrochloride, chlorpheniramine maleate, and ambroxol hydrochloride in bulk and tablet dosge form. Our current research is different from existing research studies. Ludipress® is an additive or excipient consisting of 93% lactose, 3.5% Kollidon® 30, and Kollidon CL. Lactose functions as a carrier and filler, Kollidon®30 as a binding agent, and Kollidon CL as a disintegrator. So that Ludipress® is a granule with a good flow rate, is not too hygroscopic, and has a strong tie. This makes the process of mixing with active substances become more homogeneous and can be pressed directly so as to produce high-quality tablets. Tablet formulations using Ludipress® only require active substances, Ludipress®, and lubricants, and then mixed and can be directly pressed [15, 16]. Ambroxol Hydrochloride is a compound used as a cough medicine that is as a mucolytic. Mucolytic is a drug that can thin the airway secretions by breaking the threads of mucoproteins and mucopolysaccharides from mucus. Mucus removal becomes easy, so it relieves breathing. Ambroxol is completely absorbed after oral administration. It breaks up phlegm, used in the treatment of respiratory diseases associated with viscid or excessive mucus. Recently, a hypothesis suggested that it may have a potential role in the treatment of Paget's disease of bone, Parkinsonism, and other common diseases of aging-associated diseases involving dysfunction of autophagy. The dose of Ambroxol Hydrochloride is between 30 mg to 120 mg per day for adults [17-19]. In this study, ambroxol, HCl tablets were made by direct pressing using a variation of Ludipress® and lactose additives in an effort to accelerate the solubility of active substances. MATERIALS AND METHODS Tools Dissolution type 2 (Sotax), UV-VIS spectrophotometer (Analytic Jena), tapped density test equipment(Varian 50-1300), hardness tester (Erweka), tablet friability test equipment (Varian 453200), analytical balance (Mettler Toledo), single punch tablet machines (Korsch), crushed time test equipment (Erweka ZT3), sieves, thermometers, calipers, and glassware commonly used in laboratories. I In nt te e r rn na a t ti io o n na al l J Jo ou u r rn na a l l o of f A Ap pp p l li ie e d d P Ph h a ar rm m a ac ce e u u t ti ic cs s ISSN- 0975-7058 Vol 12, Issue 3, 2020